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PAIN MEDICINE

The Safety and Efficacy of a Fentanyl Patient-Controlled Transdermal System for Acute Postoperative Analgesia: A Multicenter, Placebo-Controlled Trial

Jacques E. Chelly, MD PhD, MBA^*, Jeffrey Grass, MD, Timothy W. Houseman, MD, Harold Minkowitz, MD, and Alex Pue, MD^||

*University of Pittsburgh Medical Center and The Western Pennsylvania Hospital, Pittsburgh, Pennsylvania, Thomas Hospital, Fairhope, Alabama, Memorial City Hospital, Houston, Texas, and the ||Mary Birch Hospital for Women, San Diego, California

Address correspondence and reprint requests to Jacques E. Chelly, MD, PhD, MBA, Professor of Anesthesiology and Orthopedic Surgery, and Vice Chairman of Clinical Research, Director of Orthopedic Anesthesia and Acute Pain Services Department of Anesthesiology, Pittsburgh School of Medicine, A-1305 Scaife Hall, 3550 Terrace Street, Pittsburgh, PA 15261. Address email to chelje{at}anes.upmc.edu

A noninvasive method of delivery of parenteral opioids for management of acute pain may offer logistic advantages for patients and nursing staff. A patient-controlled transdermal system (PCTS) under development consists of a preprogrammed, self-contained drug-delivery system that uses electrotransport technology (E-TRANS®, ALZA Corp, Mountain View, CA) to deliver 40 µg of fentanyl HCl over 10 min per on-demand dose for patient-controlled analgesia (PCA). In this randomized, double-blinded, placebo-controlled trial we compared the efficacy and safety of on-demand fentanyl HCl PCTS 40 µg against placebo for postoperative pain up to 24 h after major abdominal, orthopedic, or thoracic surgery in 205 patients. The primary efficacy measurement was the percentage of patients withdrawn from the study because of inadequate analgesia after completing at least 3 h of treatment. Secondary efficacy measures included mean pain intensity (using visual analog scales), patient global assessments, and investigator global assessments. Of 189 patients considered evaluable for efficacy, 25% of patients in the fentanyl HCl PCTS 40 µg group withdrew because of inadequate analgesia, compared with 40.4% of the placebo group (P < 0.05). Use of fentanyl HCl PCTS 40 µg was associated with lower VAS scores and higher mean patient and investigator global assessment scores compared with placebo. No patient experienced clinically relevant respiratory depression. This study showed that a fentanyl HCl PCTS 40 µg for PCA was superior to placebo and well tolerated for the control of moderate to severe postoperative pain for up to 24 h after major surgery.

IMPLICATIONS: This multicenter, randomized, double-blinded, placebo-controlled trial showed that an on-demand fentanyl HCl patient-controlled transdermal system (PCTS) was superior to placebo and well tolerated for the control of moderate to severe postoperative pain for up to 24 h after major surgery. This fentanyl HCl PCTS is a preprogrammed, needle free, self-contained drug-delivery system that uses electrotransport technology (iontophoresis) to deliver 40 µg of fentanyl per on-demand dose.

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